Remote Contract- Biostatistician (Science & Biotech)
REMOTE, GA 30312
Recruited by: Ellen Curnin | Recruiter | SimulStat Inc. See all my Jobs

Hiring Company: SimulStat's client
Industry: Science & Biotech
Compensation: Depends On Experience
Expires: Aug 21, 2023

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Job Description

12 month remote renewable contract

Top 3 Must Have Skill Sets:
* SAS experience
* Pharma industry experience
* Statistical Analysis experience
* Experience with claims databases (big plus)
Work under the direction of Medical Affairs Statistics Disease Lead.
• Actively provide statistical support to the Medical Affairs Department.
• Provide statistical support for publications, presentations, posters at medical meetings and any other requests not covered in the clinical study report. This includes meta-analysis, multivariate analysis, use of graphical R and SAS tools and support for hypothesis -driven as well as exploratory analyses.
• Interact with authors, referees and in-house reviewers in the preparation of publications, presentation and posters.
• Provide statistical reviews of proposed design and analysis of protocols for investigator initiated trials.
• Provide statistical input for design, sample size and protocol for Medical Affairs studies.
• Provide review of statistical analysis plan including table shells, analysis dataset specifications and all deliverables for Medical Affairs studies provided by CRO.
• Manage outside CROs and consultants as needed.
• Support regulatory responses using Medical affairs interventional and registry data.
• Work closely with different departments in the company (regulatory, clinical, marketing, data management, health economics, etc.) and provide statistical support for a variety of functional groups.

KNOWLEDGE/SKILLS/ABILITIES (KSA's):
• Masters in Statistics with a focus on statistical methods appropriate for clinical trials is essential. Ph.D. in statistics preferred.
• Minimum of 3 years of solid experience and demonstrated skill in the planning, analysis and reporting of clinical trials.
• Experience with time-to-event data.
• Good planning and project management skills.
• Knowledge and curiosity of currently acceptable statistical methodologies.
• Excellent SAS skills including report generation. Willingness to be hands-on when needed.
• Knowledge of MS Office products (Word, Excel, PowerPoint).
• Excellent communication, writing and organizational skills is essential.
• Demonstrated ability to work in a team environment with clinicians, clinical monitors, data managers, programmers and medical writers.